MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
NCT ID: NCT04896801
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2021-08-10
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MR-guided prostate stereotactic body radiotherapy
Patients will receive MR-guided RT in 5 fractions over 7 days (daily excluding weekend, i.e. start on Wednesday or Thursday, until Tuesday or Wednesday respectively the week after).
MR-guided RT
The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy \< 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT
Interventions
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MR-guided RT
The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy \< 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate adenocarcinoma
* Low risk: cT1c-T2a, Gleason score 6, PSA \< 10ng/mL
* Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, \< 50% positive biopsy cores)
* Unfavorable intermediate risk: \> 1 intermediate risk factor, Gleason 4+3, \> 50% positive biopsy cores)
* Limited high risk: cT3a with PSA \< 40ng/mL or cT2a-c with a Gleason score \> 7 and/or a PSA \> 20ng/mL but \< 40ng/mL
* World Health Organization performance score 0-2
* Written informed consent
Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
Exclusion Criteria
* International Prostate Symptom Score (IPSS) \> 19
* Prostate volume \> 100cc on transrectal ultrasound (TRUS)
* Stage cT3b-T4
* N1 disease (clinically or pathologically)
* M1 disease (clinically or pathologically)
* PSA \> 40ng/mL
* inflammatory bowel disease
* immunosuppressive medications
* prior pelvic RT
* contra-indications for MRI
18 Years
MALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Mark De Ridder
Principal Investigator
Principal Investigators
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Mark De Ridder, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Locations
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Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO7
Identifier Type: -
Identifier Source: org_study_id